MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
NCT ID: NCT03374553
Last Updated: 2022-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2017-11-25
2021-02-08
Brief Summary
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The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MINIject DO Integrated System CS636 (MINI DO636)
MINIject 636 implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive glaucoma surgical intervention.
The intervention is to be performed as stand-alone surgery. In this arm the implant is placed using Dual Operator Delivery Tool (DODT).
MINI DO636
MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool.
The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach.
For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant.
Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT).
DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636).
MINIject SO Integrated System CS636 (MINI SO636)
MINIject 636 implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive glaucoma surgical intervention.
The intervention is to be performed as stand-alone surgery. In this arm the implant is placed using Single Operator Delivery Tool (SODT).
MINI SO636
MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool.
The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach.
For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant.
Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT).
DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636).
Interventions
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MINI DO636
MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool.
The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach.
For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant.
Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT).
DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636).
MINI SO636
MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool.
The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach.
For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant.
Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT).
DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636).
Eligibility Criteria
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Inclusion Criteria
* Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
* Glaucoma not adequately controlled
Exclusion Criteria
* Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
* Neovascular glaucoma in the study eye
* Prior glaucoma surgery in the study eye
* Clinically significant corneal disease
* Patients with poor vision
18 Years
ALL
No
Sponsors
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iSTAR Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Zubair Hussain, PhD
Role: STUDY_DIRECTOR
iSTAR Medical
Locations
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Clínica Oftalmológica del Caribe
Barranquilla, , Colombia
Maxivision Eye Hospital
Hyderabad, Telangana, India
Panama Eye Center
Panama City, , Panama
Countries
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Other Identifiers
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ISM05
Identifier Type: -
Identifier Source: org_study_id
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